BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMBRACE2 WATCH

    MDR report key: 18740187 · Received February 16, 2024

    Report

    Report Number
    MW5151782
    Event Type
    Malfunction
    Date Received
    February 16, 2024
    Date of Event
    February 14, 2024
    Report Date
    February 14, 2024
    Manufacturer
    EMPATICA S.R.L.
    Product Code
    POS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    EI
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAVE AN EMPATICA EMBRACE2 SEIZURE DETECTION WATCH WHICH SENDS ALERTS (VIA AN APP ON MY PHONE) TO DESIGNATED CONTACTS IF IT DETECTS A SEIZURE MAY BE HAPPENING. THERE IS A 15 SECOND TIMEFRAME FOR ME TO CANCEL THE ALERT BEING SENT FROM MY PHONE IF ITS S 'FALSE ALARM'. ON (B)(6) 2024, AT 17:30, IT DETECTED A POSSIBLE SEIZURE AND THE APP MESSAGE APPEARED ON MY PHONE AS ALERT SENT TO MY CONTACT HOWEVER MY CONTACT DIDN'T RECEIVE THE ALERT UNTIL 17:57. IN THIS INSTANCE IT WAS A FALSE ALARM THAT I DIDN'T MANAGE TO CANCEL IN THE 15 SECOND WINDOW AND HENCE ALERT SENT MESSAGE. AFTER THE 15 SECOND WINDOW IT GIVES THE OPTION TO SEND AN SMS TO LET THE CONTACT KNOW THAT I'M OKAY WHICH I IMMEDIATELY SELECTED AT 17:30 BUT THIS MESSAGE WAS ALSO NOT RECEIVED BY MY CONTACT UNTIL 17:57. I WAS LUCKY IN THIS INSTANCE THAT I WAS NOT HAVING A SEIZURE HOWEVER THE WATCH DID NOT WORK AS INTENDED AND FAILED TO MESSAGE MY CONTACT UNTIL 30MINS AFTER THE SEIZURE WAS DETECTED. HAD THIS BEEN AN ACTUAL SEIZURE THE IMPACT COULD HAVE BEEN VERY SEVERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1642006 EMBRACE2 WATCH PHYSIOLOGICAL SIGNAL BASED SEIZURE MONITORING SYSTEM POS EMPATICA S.R.L. EMBRACE2

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female KEPPRA 750MG TWICE DAILY.| VITAMIN B1.| VITAMIN B6.| VITAMIN D3.